Manager - Quality Control
2 weeks ago
Adapts and implements departmental plans and priorities base don division scorecard to address local business and operational challenges.
- Responsible for all aspects of quality control activities associated with final drug substances and their intermediates including but not limited to batch release testing, stability programs and annual product review.
- Ensures all analytical activities in the laboratory comply with cGMP as well as safety and environmental requirements and are completed in a timely and cost-effective manner to meet supply targets.
- Ensures quality systems are continually reviewed and any compliance gaps and new requirements are identified with necessary actions taken. Leads laboratory investigations in accordance with MSD guidelines and cGMP requirements and implement robust and sustainable corrective and preventive actions in a timely manner.
- Ensures all direct reports receive required cGMP, EHS and role-related training required to work safely and in compliance with regulatory requirements and as defined by their learning plan. Provides coaching and mentoring for personal and professional development of staff.
- Manages the transfer of analytical methods, specifications and development knowledge for the drug substances and their associated manufacturing processes from development sites and between supply sites.
- Ensures that the safety measures associated with chemical and equipment handling are satisfactory and in compliance with MSD EHS requirements.
- Maintains outside contacts in the scientific community, universities, government and other outside laboratories in relation to analytical chemistry. Monitors industry trends, new technology initiatives and worldwide analytical regulatory guidance.
- Forecasts resource needs, and prepares and manages laboratory capital and expense budgets and operates within approved budgets.
- Develops a continuous improvement framework within the team, identifies and implements projects and improvements, actively supports site improvement programs to increase accuracy, compliance, productivity, and reduce cycle time, inventory and waste.
- Any other duties as assigned by the Manager.
**Search Firm Representatives Please Read Carefully**
**Employee Status**:
Regular
**Relocation**:
No relocation
**VISA Sponsorship**:
**Travel Requirements**:
**Flexible Work Arrangements**:
**Shift**:
**Valid Driving License**:
**Hazardous Material(s)**:
**Number of Openings**:
1
**Requisition ID**:R214450
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